CE 5: Beyond Animal Models: Navigating New Approach Methodologies in Modern Drug Development with Case Study Examples

As the pharma industry evolves toward more ethical, efficient, and human-relevant practices, New Approach Methodologies (NAMs) are reshaping the landscape of drug discovery and safety assessment. This course explores the scientific, regulatory, and technological dimensions of NAMs, including in vitro systems, computational modeling, and organ-on-a-chip platforms. We will examine the validation challenges of NAMs, and the opportunities they present for accelerating drug development. In addition, we will be discussing the U.S. Food and Drug Administration’s 2025 roadmap to reduce animal testing in preclinical safety studies, particularly in the development of monoclonal antibody (mAb) therapies. This strategic plan encourages the use of scientifically validated NAMs in Investigational New Drug (IND) applications. Through case studies, attendees will gain a comprehensive understanding of how NAMs can be integrated into modern workflows to enhance predictivity, reduce costs, and align with global regulatory trends. This course is ideal for professionals and students in pharmacology, toxicology, regulatory science, and biomedical innovation.

CE Course Chair: Kristina Howard, DVM, PhD, DABT – US FDA
CE Course Chair: Alok Sharma, BVSc, MVSc, MS, PhD, DACVP, DABT, FIATP – Labcorp
CE Course Speaker: Radhakrishna Sura, BVSc, PhD, DACVP, DABT, Fellow IATP – Gilead Sciences, Inc. 
CE Course Speaker: Dinesh S. Bangari, BVSc & AH, PhD, DACVP – Sanofi
CE Course Speaker: John S. Kendrick, PhD – Labcorp